MigraMax oral powder sachets

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Aspirin DL-Lysine; Metoclopramide hydrochloride

Disponible depuis:

Zentiva Pharma UK Ltd

Code ATC:

N02BA51

DCI (Dénomination commune internationale):

Aspirin DL-Lysine; Metoclopramide hydrochloride

Dosage:

900mg ; 10mg

forme pharmaceutique:

Powder for oral solution

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 04070401; GTIN: 5060093000696 5060093000702

Notice patient

1
PACKAGE LEAFLET:
INFORMATION FOR THE USER
MIGRAMAX 900MG/10MG, POWDER FOR ORAL SOLUTION
Acetylsalicylic acid (as DL-lysine acetylsalicylate)
Metoclopramide hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell
your doctor or pharmacist.
IN THIS LEAFLET:
1. What MigraMax is and what it is used for
2. Before you take MigraMax
3. How to take MigraMax
4. Possible side effects
5. How to store MigraMax
6. Further information
1. WHAT MIGRAMAX IS AND WHAT IT IS USED FOR
The name of your medicine is MigraMax 900mg/10mg Powder for oral
solution (called MigraMax in this
leaflet).
WHAT MIGRAMAX CONTAINS
MigraMax contains two different medicines. These are called:
• METOCLOPRAMIDE HYDROCHLORIDE: This belongs to a group of medicines
called anti-emetics. It works
on muscles in the upper part of the digestive system causing your
stomach to empty. It also works on
a part of your brain that prevents you from feeling sick (nausea) or
being sick (vomiting).
• DL-LYSINE ACETYLSALICYLATE: This belongs to a group of medicines
called painkillers (analgesics). DL-
lysine acetylsalicylate is broken down in your body to aspirin
(acetylsalicylic acid). This works by
blocking a substance that naturally occurs in your body called
cyclo-oxygenase. Cyclo-oxygenase makes
some of the chemicals that cause pain. If it is blocked, pain is
relieved.
WHAT MIGRAMAX IS USED FOR
MigraMax is used to treat the signs of migraine, such as headache,
feeling sick (nausea) or being sick
(vomiting) in adults 18 years and over.
2. BEFORE YOU TAKE MIGRAMAX
DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF:
x
You are allergic (hypersensitive) to:
-
Me

Résumé des caractéristiques du produit

OBJECT 1
MIGRAMAX 900MG/10MG POWDER FOR ORAL
SOLUTION
Summary of Product Characteristics Updated 10-Nov-2016 | Zentiva
1. Name of the medicinal product
Migramax 900 mg/10 mg Powder for oral solution
2. Qualitative and quantitative composition
Active ingredients
DL-lysine acetylsalicylate
equivalent to acetylsalicylic acid
Metoclopramide (INN) hydrochloride EP
equivalent in terms of the anhydrous substance
to:
Per sachet
1,620mg
900mg
10.54mg
10mg
3. Pharmaceutical form
Sachet containing powder for oral solution
4. Clinical particulars
4.1 Therapeutic indications
Adult population
MigraMax is indicated for the treatment of migraine-associated
symptoms such as headache, nausea and
vomiting.
4.2 Posology and method of administration
For oral administration only.
MigraMax must be dissolved completely in some water before taking.
Renal and hepatic insufficiency
Caution should be exercised in significant renal or hepatic
impairment. Metoclopramide is metabolised in
the liver and eliminated mainly via the kidney. A dose reduction may
be necessary.
Adults (aged 18 years and older) and elderly
One sachet should be taken at the first warning of a migraine attack.
A second sachet may be taken two
hours later if the symptoms have not resolved. Do not exceed three
sachets in a 24 hour period.
Paediatric population including adolescents
Use in children less than 1 year of age is contraindicated (see
section 4.3)
Use in children and adolescents between the ages of 1 and 18 years is
not recommended.
Treatment should not exceed 3 months due to the presence of
metoclopramide (see sections 4.4 and 4.8)
4.3 Contraindications
- Hypersensitivity to metoclopramide, salicylates or any of the
components.
- Patients with pre-existing mastocytosis, in whom the use of
acetylsalicyclic acid may induce severe
hypersensitivity reactions (including circulatory shock with flushing,
hypotension, tachycardia and
vomiting). In these patients, aspirin has the potential to induce
anaphylaxis either on its own or in
combination with food and/or exercis